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High MAP in Septic Shock With Hypertension

Primary Purpose

Septic Shock

Status
Completed
Phase
Not Applicable
Locations
China
Study Type
Interventional
Intervention
NE
Sponsored by
Southeast University, China
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional treatment trial for Septic Shock focused on measuring septic shock, microcirculation, norepinephrine, fluid

Eligibility Criteria

18 Years - 90 Years (Adult, Older Adult)All SexesAccepts Healthy Volunteers

Inclusion Criteria:

  • Patients with septic shock for less than 24 hours
  • Fluid resuscitation was performed according to the guideline for treating septic shock to maintain the central venous pressure (CVP) for more than 8 mm Hg and central venous oxygen saturation for more than 70%
  • Patients requiring norepinephrine (NE) to maintain a MAP of 65 mm Hg. Septic shock patients with fluid resuscitation after CVP > 8mmHg and mean blood pressure > 65 mmHg

Exclusion Criteria:

  • Pregnancy
  • Age < 18 years
  • Inability to acquire the usual level of MAP
  • Refusal of consent by the patient or relative
  • Participation in other trials during the last three months
  • Hypertensive patients without hypertension treatment

Sites / Locations

  • Zhongda Hospital Southeast University

Arms of the Study

Arm 1

Arm Type

Experimental

Arm Label

NE group

Arm Description

Adjust NE dose to titrate MAP to usual level regardless of fluid responsiveness when after EGDT.

Outcomes

Primary Outcome Measures

Mean Arterial Pressure
As chronic hypertensive patients were supposed to have undergone more blood pressure measurements in daily life than non-hypertensive ones, the averaged MAP acquired from patients' physical examination records of the last two years was registered and assumed as patients' usual level of MAP and target MAP. If patients' medical records were incomplete, a detailed enquiry about the target MAP to their next kin was performed. After stabilization for 30 min, basal measurements including hemodynamic and microcirculatory measurements were taken, 20 min apart, the NE doses were increased to titrate MAP to the target level. Patients were allowed to stabilize for 30 min before taking new measurements.

Secondary Outcome Measures

Perfused Vessel Density
Increasing MAP from 65 mm Hg to target level. The sublingual microcirculation was measured by sidestream dark field, including the parameters of perfused vessel density

Full Information

First Posted
September 28, 2011
Last Updated
June 13, 2017
Sponsor
Southeast University, China
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1. Study Identification

Unique Protocol Identification Number
NCT01443494
Brief Title
High MAP in Septic Shock With Hypertension
Official Title
High Mean Arterial Pressure Target Improves Microcirculation in Septic Shock Patients With Previous Hypertension
Study Type
Interventional

2. Study Status

Record Verification Date
June 2017
Overall Recruitment Status
Completed
Study Start Date
June 2011 (undefined)
Primary Completion Date
June 2012 (Actual)
Study Completion Date
June 2012 (Actual)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Principal Investigator
Name of the Sponsor
Southeast University, China

4. Oversight

Data Monitoring Committee
No

5. Study Description

Brief Summary
We hypothesized that the increase in MAP from 65 mmHg to patients' usual level improved sublingual microcirculation.
Detailed Description
The effect of mean arterial pressure (MAP) titration to higher level on microcirculation in septic shock patients with previous hypertension remains unknown. Our goal was to assess the effect of MAP titration to patients' usual level on microcirculation in septic shock patients with previous hypertension. We hypothesized that the increase in MAP from 65 mmHg to patients' usual level improved sublingual microcirculation.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Septic Shock
Keywords
septic shock, microcirculation, norepinephrine, fluid

7. Study Design

Primary Purpose
Treatment
Study Phase
Not Applicable
Interventional Study Model
Single Group Assignment
Masking
None (Open Label)
Allocation
N/A
Enrollment
19 (Actual)

8. Arms, Groups, and Interventions

Arm Title
NE group
Arm Type
Experimental
Arm Description
Adjust NE dose to titrate MAP to usual level regardless of fluid responsiveness when after EGDT.
Intervention Type
Other
Intervention Name(s)
NE
Intervention Description
norepinephine
Primary Outcome Measure Information:
Title
Mean Arterial Pressure
Description
As chronic hypertensive patients were supposed to have undergone more blood pressure measurements in daily life than non-hypertensive ones, the averaged MAP acquired from patients' physical examination records of the last two years was registered and assumed as patients' usual level of MAP and target MAP. If patients' medical records were incomplete, a detailed enquiry about the target MAP to their next kin was performed. After stabilization for 30 min, basal measurements including hemodynamic and microcirculatory measurements were taken, 20 min apart, the NE doses were increased to titrate MAP to the target level. Patients were allowed to stabilize for 30 min before taking new measurements.
Time Frame
Target MAP stabilization for 30 min
Secondary Outcome Measure Information:
Title
Perfused Vessel Density
Description
Increasing MAP from 65 mm Hg to target level. The sublingual microcirculation was measured by sidestream dark field, including the parameters of perfused vessel density
Time Frame
Target MAP stabilization for 30 min

10. Eligibility

Sex
All
Minimum Age & Unit of Time
18 Years
Maximum Age & Unit of Time
90 Years
Accepts Healthy Volunteers
Accepts Healthy Volunteers
Eligibility Criteria
Inclusion Criteria: Patients with septic shock for less than 24 hours Fluid resuscitation was performed according to the guideline for treating septic shock to maintain the central venous pressure (CVP) for more than 8 mm Hg and central venous oxygen saturation for more than 70% Patients requiring norepinephrine (NE) to maintain a MAP of 65 mm Hg. Septic shock patients with fluid resuscitation after CVP > 8mmHg and mean blood pressure > 65 mmHg Exclusion Criteria: Pregnancy Age < 18 years Inability to acquire the usual level of MAP Refusal of consent by the patient or relative Participation in other trials during the last three months Hypertensive patients without hypertension treatment
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Haibo Qiu, MD,PhD
Organizational Affiliation
Southeast University
Official's Role
Study Director
Facility Information:
Facility Name
Zhongda Hospital Southeast University
City
Nanjing
State/Province
Jiangsu
ZIP/Postal Code
210000
Country
China

12. IPD Sharing Statement

Citations:
PubMed Identifier
15343008
Citation
Sakr Y, Dubois MJ, De Backer D, Creteur J, Vincent JL. Persistent microcirculatory alterations are associated with organ failure and death in patients with septic shock. Crit Care Med. 2004 Sep;32(9):1825-31. doi: 10.1097/01.ccm.0000138558.16257.3f.
Results Reference
background
PubMed Identifier
23363690
Citation
Correa TD, Vuda M, Takala J, Djafarzadeh S, Silva E, Jakob SM. Increasing mean arterial blood pressure in sepsis: effects on fluid balance, vasopressor load and renal function. Crit Care. 2013 Jan 30;17(1):R21. doi: 10.1186/cc12495.
Results Reference
background
PubMed Identifier
23534963
Citation
Beloncle F, Lerolle N, Radermacher P, Asfar P. Target blood pressure in sepsis: between a rock and a hard place. Crit Care. 2013 Mar 26;17(2):126. doi: 10.1186/cc12543.
Results Reference
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PubMed Identifier
17584921
Citation
Sevransky JE, Nour S, Susla GM, Needham DM, Hollenberg S, Pronovost P. Hemodynamic goals in randomized clinical trials in patients with sepsis: a systematic review of the literature. Crit Care. 2007;11(3):R67. doi: 10.1186/cc5948.
Results Reference
background
PubMed Identifier
10966242
Citation
LeDoux D, Astiz ME, Carpati CM, Rackow EC. Effects of perfusion pressure on tissue perfusion in septic shock. Crit Care Med. 2000 Aug;28(8):2729-32. doi: 10.1097/00003246-200008000-00007.
Results Reference
background
PubMed Identifier
19384212
Citation
Jhanji S, Stirling S, Patel N, Hinds CJ, Pearse RM. The effect of increasing doses of norepinephrine on tissue oxygenation and microvascular flow in patients with septic shock. Crit Care Med. 2009 Jun;37(6):1961-6. doi: 10.1097/CCM.0b013e3181a00a1c.
Results Reference
background
PubMed Identifier
19534818
Citation
Dubin A, Pozo MO, Casabella CA, Palizas F Jr, Murias G, Moseinco MC, Kanoore Edul VS, Palizas F, Estenssoro E, Ince C. Increasing arterial blood pressure with norepinephrine does not improve microcirculatory blood flow: a prospective study. Crit Care. 2009;13(3):R92. doi: 10.1186/cc7922. Epub 2009 Jun 17.
Results Reference
background
PubMed Identifier
21936903
Citation
Thooft A, Favory R, Salgado DR, Taccone FS, Donadello K, De Backer D, Creteur J, Vincent JL. Effects of changes in arterial pressure on organ perfusion during septic shock. Crit Care. 2011;15(5):R222. doi: 10.1186/cc10462. Epub 2011 Sep 21.
Results Reference
background
PubMed Identifier
25887027
Citation
Xu JY, Ma SQ, Pan C, He HL, Cai SX, Hu SL, Liu AR, Liu L, Huang YZ, Guo FM, Yang Y, Qiu HB. A high mean arterial pressure target is associated with improved microcirculation in septic shock patients with previous hypertension: a prospective open label study. Crit Care. 2015 Mar 30;19(1):130. doi: 10.1186/s13054-015-0866-0.
Results Reference
derived

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High MAP in Septic Shock With Hypertension

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